| Project Coordinator (Regulatory Affairs) -- Fremont, CA |
Author: Robert McLaughlin
Date: 11-02-11 22:15
This is a part-time regular position with benefits.
What you do in your career can positively affect 1 out of every 2 people? You can be part of a dedicated group of people who connect with a valued mission to prevent cancer and to reduce its burden where it cannot yet be prevented?
The Cancer prevention Institute of California (CPIC) is looking for a Project Coordinator to coordinate and facilitate various activities the Office of Legal and Regulatory Affairs, mainly those of the Institutional Review Board (IRB) that oversees research protocols for ethics and compliance with human subjects protection regulations. Work with the In-House Counsel/Compliance Officer to administer other organizational compliance and regulatory activities/programs.
TO APPLY: https://home.eease.adp.com/recruit2/?id=792621&t=1 .
PRINCIPAL DUTIES
The Project Coordinator will work with the IRB Administrator (In-House Counsel/Compliance Officer) and the Administrative Assistant to provide all necessary support for IRB functions including:
· Protocol Calendaring: ensure the timely processing of IRB submissions, especially submissions for continuing review using data maintained in the IRB Database.
· Consultation and Guidance: work with investigators in their development of IRB submissions where advice and guidance are needed, and/or where novel methods, areas of study, or vulnerable populations of potential participants may be involved in research.
· Pre-Review/Screening: review IRB submissions for completeness and conformance to CPIC policies and standards, and federal regulations.
· Protocol Processing: compile and prepare IRB submissions for timely review by the IRB; work with the IRB Administrator to facilitate IRB meetings with respect to content, logistics, and record/documentation of meetings.
· Review and Finalize Committee Agendas and Meeting Minutes.
· IRB Action Correspondence: draft complex and oversee standard communications of IRB determinations using the IRB Database tools, conveying information with accuracy, completeness, professionalism, and sensitivity to investigators’ personal investments in their work product.
· Review of Investigator Responses: receive and process responses and inquiries from investigators regarding conditional approvals, appeals, re-submissions, and requests for administrative approvals.
· Document Management: Work with IRB Administrator and Administrative Assistant to manage records and to ensure the accuracy of the IRB Database, paper record, and electronic files in conformance with CPIC policies and federal requirements. Oversee migration of old paper records to electronic format (Adobe-PDF), and electronic archive (shared network drive)
· Collaboration with IRB Administrator to resolve and report unanticipated problems and/or adverse events
· Collaboration with IRB co-chairs and members for processing expedited reviews and other matters.
· Work with In-House Counsel/Compliance Officer to administer other compliance activities/programs as time permits, including, for example, Conflict of Interest, Confidentiality, Business Ethics, etc.
QUALIFICATIONS:·
BA/BS degree in the physical or social sciences or related field, and three years experience in project management, health research, or related field, or equivalent combination of education and experience.
· MA/MPH preferred.
· 1 year experience in IRB administration highly preferred.
· Certification as an IRB manager (CIM) or IRB professional (CIP) preferred.
· Basic knowledge of federal regulations pertaining to human subjects research and medical privacy.
· Excellent written and oral communication skills.
· Strong analytic skills.
· Careful attention to detail.
· Strict adherence to deadlines for routine and non-routine tasks.
· Excellent time management skills and abilities to work independently, set priorities, and manage multiple ongoing activities.
· Excellent Microsoft Offices skills; experience with Microsoft Access Databases and Adobe applications preferred.
· Able to walk and carry up to 25 pounds (1 file box) of records and documentation between on-site meetings, workspaces, and copy room.
· Must be able to sit for extended periods of time for reading, writing, and computer work.
TO APPLY: http://tinyurl.com/3o7f4oz
About CPIC
The Cancer Prevention Institute of California (CPIC), formerly known as the Northern California Cancer Center (NCCC), is dedicated to preventing cancer through population-based research and community education. An independent research organization, CPIC is an established, nationally recognized leader in understanding who gets cancer and why, and how to improve the quality of life for individuals living with cancer.
An equal opportunity employer, CPIC offers an attractive compensation package, including exceptional benefits and a friendly, collaborative working environment. We are located in Fremont, California, immediately adjacent to BART, an ideal commute option.
For more information about CPIC visit: www.cpic.org
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Author |
Date |
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Project Coordinator (Regulatory Affairs) -- Fremont, CA |
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Robert McLaughlin |
11-02-11 22:15 |
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